PIRFENIDONE ZENTIVA 801 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Pirfenidone Zentiva 267 mg film-coated tablets EFG

Pirfenidone Zentiva 801 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Pirfenidone Zentiva and what is it used for
2. What you need to know before you take Pirfenidone Zentiva
3. How to take Pirfenidone Zentiva
4. Possible side effects
5. Storage of Pirfenidone Zentiva
6. Contents of the pack and other information

1. What is Pirfenidone Zentiva and what is it used for

Pirfenidone Zentiva contains the active substance pirfenidone and is used for the treatment of Idiopathic Pulmonary Fibrosis (IPF) in adults.

IPF is a disease in which the tissue of the lungs becomes swollen and scarred over time, making it difficult to breathe deeply. In these circumstances, the lungs have difficulty functioning properly. Pirfenidone helps reduce scarring and swelling of the lungs, and helps you breathe better.

2. What you need to know before you take Pirfenidone Zentiva

Do not take Pirfenidone Zentiva

• if you are allergic to pirfenidona or any of the other ingredients of this medicine (listed in section 6)
• if you have previously had angioedema with pirfenidone, including symptoms such as swelling of the face, lips and/or tongue that may be associated with difficulty breathing or wheezing
• if you are taking a medicine called fluvoxamine (used to treat depression and obsessive-compulsive disorder [OCD])
• if you have severe or terminal liver disease
• if you have severe or terminal kidney disease that requires dialysis.

If any of the above applies to you, do not take pirfenidone. If you are in doubt, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting pirfenidone.

• You may have increased sensitivity to sunlight (photosensitivity reaction) when taking pirfenidone. Avoid the sun (also UVA lamps) while taking this medicine. Use a daily sunscreen and cover your arms, legs, and head to reduce exposure to sunlight (see section 4: Possible side effects).
• Do not take other medicines, such as tetracycline antibiotics (e.g. doxycycline), that may increase your sensitivity to sunlight.
• You should inform your doctor if you have kidney problems.
• You should inform your doctor if you have liver problems of mild to moderate severity.
• You should avoid smoking before and during treatment with pirfenidone. Tobacco can reduce the effect of this medicine.
• Pirfenidone may cause dizziness and fatigue. Be careful if you need to perform activities that require attention and coordination.
• Pirfenidone may cause weight loss. Your doctor will monitor your weight while you are taking this medicine.
• Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in relation to treatment with pirfenidone. Stop using this medicine and seek immediate medical attention if you notice any of the symptoms related to severe skin reactions described in section 4.

Pirfenidone may cause serious liver problems. Some cases have been fatal. You will need to have a blood test before starting to take this medicine, once a month for the first 6 months, and then every 3 months while taking this medicine, to check your liver is working properly. It is important that you have these blood tests periodically throughout the time you are taking pirfenidone.

Children and adolescents

The administration of pirfenidone is not recommended in children and adolescents under 18 years of age.

Other medicines and Pirfenidone Zentiva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This is especially important if you are taking the following medicines, as they may alter the effect of pirfenidone.

The following medicines may increase the side effects of pirfenidone:

• enoxacin (a type of antibiotic)
• ciprofloxacin (a type of antibiotic)
• amiodarone (used to treat certain types of heart conditions)
• propafenone (used to treat certain types of heart conditions)
• fluvoxamine (used to treat depression and obsessive-compulsive disorder (OCD)).

The following medicines may reduce the effectiveness of pirfenidone:

• omeprazole (used to treat disorders such as indigestion, gastroesophageal reflux disease)
• rifampicin (a type of antibiotic).

Taking Pirfenidone Zentiva with food and drinks

Do not drink grapefruit juice while taking this medicine. Grapefruit juice may make this medicine not work properly.

Pregnancy and breastfeeding

As a precautionary measure, it is preferable to avoid the use of this medicine if you are pregnant, planning to become pregnant, or think you may be pregnant, as the potential risks to the fetus are not known.

If you are breastfeeding or planning to breastfeed, consult your doctor or pharmacist before taking this medicine. Since it is not known whether pirfenidone is excreted in breast milk, your doctor will explain the risks and benefits of taking this medicine during breastfeeding if you decide to do so.

Driving and using machines

Do not drive or operate machinery if you feel dizzy or tired after taking pirfenidone.

Pirfenidone Zentiva contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

This medicine contains less than 1mmol of sodium (23 mg) per tablet; this is, essentially “sodium-free”.

3. How to take Pirfenidone Zentiva

Treatment with pirfenidone should be initiated and supervised by specialist doctors with experience in the diagnosis and treatment of IPF.

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Normally, you will be given this medicine by gradually increasing the dose as follows:

• for the first 7 days, take a dose of 267 mg (1 yellow tablet), 3 times a day with food (a total of 801 mg/day)
• between days 8 and 14, take a dose of 534 mg (2 yellow tablets), 3 times a day with food (a total of 1,602 mg/day)
• from day 15 (maintenance), take a dose of 801 mg (3 yellow tablets or 1 brown tablet), 3 times a day with food (a total of 2,403 mg/day).

The recommended maintenance dose of pirfenidone is 801 mg (3 yellow tablets or 1 brown tablet) three times a day with food, a total of 2,403 mg/day.

Swallow the tablets whole with water, during or after a meal to reduce the risk of side effects such as nausea (feeling unwell) and dizziness. If symptoms persist, consult your doctor.

Dose reduction due to side effects

It is possible that your doctor may decide to reduce the dose if you experience side effects such as stomach problems, skin reactions to sunlight or UVA lamps, or significant changes in liver enzymes.

If you take more Pirfenidone Zentiva than you should

Go to your doctor, pharmacist or the emergency department of the nearest hospital immediately if you take more tablets than you should and take your medicine with you.

You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Pirfenidone Zentiva

If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for forgotten doses. Each dose should be separated by an interval of at least 3 hours. Do not take more tablets per day than your prescribed daily dose.

If you stop taking Pirfenidone Zentiva

In certain situations, your doctor will advise you to stop taking pirfenidone. If for any reason you stop taking this medicine for more than 14 consecutive days, your doctor will restart your treatment with a dose of 267 mg 3 times a day and gradually increase it to 801 mg 3 times a day.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking pirfenidone and seek immediate medical attention if you notice any of the following symptoms or signs

• Swelling of the face, lips or tongue, itching, rash, difficulty breathing or wheezing, or feeling of fainting, which are signs of angioedema, a severe allergic reaction or anaphylaxis.
• Yellow eyes or skin or dark urine, and possibly accompanied by itching of the skin, pain in the upper right side of the abdomen (stomach), loss of appetite, bleeding or bruising more easily than usual, or feeling tired. These could be signs of abnormal liver function and may indicate liver damage, which is a rare side effect of this medicine.
• Reddish patches or circular patches on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Other possible side effects are

If you experience any type of side effect, consult your doctor.

Very common side effects(may affect more than 1 in 10 people):

• throat or respiratory tract infections that reach the lungs and/or sinusitis
• feeling unwell (nausea)
• stomach problems, such as acid reflux, vomiting and constipation
• diarrhea
• indigestion or stomach heaviness
• weight loss
• decreased appetite
• difficulty sleeping
• fatigue
• dizziness
• headache
• difficulty breathing
• cough
• joint pain.

Common side effects(may affect up to 1 in 10 people):

• bladder infections
• drowsiness
• changes in taste
• hot flashes
• stomach problems such as bloating, abdominal pain and discomfort, heartburn and flatulence
• blood tests may indicate increased liver enzymes
• skin reactions after exposure to sunlight or UVA lamps
• skin problems such as itching, irritation or redness, dryness, rash
• muscle pain
• weakness or lack of energy
• chest pain
• sunburn.

Uncommon side effects(may affect up to 1 in 100 people):

• low sodium levels in the blood. This can cause headache, dizziness, confusion, weakness, muscle cramps or nausea and vomiting.
• blood test results may show a decrease in white blood cells.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pirfenidone Zentiva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label of the bottle, blister and carton after “EXP”. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pirfenidone Zentiva

267 mg tablets

The active substance is pirfenidone. Each film-coated tablet contains 267mg of pirfenidone.

The other ingredients are: lactose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

The film coating consists of: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172).

801 mg tablets

The active substance is pirfenidone. Each film-coated tablet contains 801 mg of pirfenidone.

The other ingredients are: lactose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

The film coating consists of: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, red iron oxide (E172) and black iron oxide (E172).

Appearance of the product and pack contents

267 mg tablets

Pirfenidone Zentiva 267 mg film-coated tablets are yellow, oval, biconvex, film-coated tablets engraved with “267”.

The blister packs contain 63 film-coated tablets (pack of 63 film-coated tablets or multiple pack consisting of 1 pack of 21 film-coated tablets and 1 pack of 42 film-coated tablets) or 252 film-coated tablets (pack of 252 film-coated tablets or multiple pack consisting of 3 packs, each containing 84 film-coated tablets).

801 mg tablets

Pirfenidone Zentiva 801 mg film-coated tablets are brown, oval, biconvex, film-coated tablets engraved with “801”.

The blister packs contain 84 film-coated tablets or 252 film-coated tablets (pack of 252 film-coated tablets or multiple pack consisting of 3 packs, each containing 84 film-coated tablets).

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Zentiva, k.s.

U kabelovny 130,

Dolni Mecholupy, 102 37

Prague 10,

Czech Republic

Manufacturer

Rontis Hellas Medical and Pharmaceutical Products S.A.

P.O. Box 3012 Larisa Industrial Area,

Larisa, 41004, Greece

or

You can obtain further information on this medicine from the local representative of the marketing authorisation holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet:August 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/